Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 10:50 AM
Study NCT ID:
NCT05633134
Status:
UNKNOWN
Last Update Posted:
2022-12-01
First Post:
2022-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2022-11-20', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative blood loss', 'timeFrame': 'Measured intraoperatively', 'description': 'Perioperative blood loss measured intraoperatively'}], 'secondaryOutcomes': [{'measure': 'Adverse events related to angiography or embolization', 'timeFrame': 'Within 2 postoperative days', 'description': 'Including symptoms of nerve compression, pelvic organ ischemia injury'}, {'measure': 'Adverse events related to surgery', 'timeFrame': 'Within 30 postoperative days', 'description': 'including poor wound healing，nerve injury，pelvic organ dysfunction'}, {'measure': 'Vascularization grade of pelvic tumors', 'timeFrame': 'At the angiographic procedure prior to embolization performed 0-24 hours before surgery', 'description': 'it contains four grades：poor、moderate、rich、abundant'}, {'measure': 'postoperative blood loss', 'timeFrame': 'Within 2 postoperative days', 'description': 'blood loss measured through the drainage within 2 postoperative days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Embolization', 'Pelvic Tumor']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.', 'detailedDescription': 'The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery，which including poor wound healing，nerve injury，and pelvic organs dysfunction. Furthermore the study aims at describing the vascularity in a series of pelvic tumors,which contains four grade：poor，moderate，rich and abundant and to correlate this with perioperative blood loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or metastatic pelvic tumor\n* Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic\n* Planned surgical resection\n\nExclusion Criteria:\n\n* Contrast medium allergy\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT05633134', 'briefTitle': 'Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes', 'orgStudyIdInfo': {'id': 'PPE-PT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precision preoperative embolization', 'description': '60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.', 'interventionNames': ['Procedure: Arteriography and precision preoperative embolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.', 'interventionNames': ['Procedure: Arteriography']}], 'interventions': [{'name': 'Arteriography and precision preoperative embolization', 'type': 'PROCEDURE', 'otherNames': ['Transcatheter arterial embolization', 'Therapeutic angiography', 'Selective arterial embolization'], 'description': 'Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.', 'armGroupLabels': ['Precision preoperative embolization']}, {'name': 'Arteriography', 'type': 'PROCEDURE', 'description': 'Arteriography of pelvic tumors 0-24 hours prior to surgery.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'XIN ZHI', 'role': 'CONTACT', 'email': 'zhixindd@163.com', 'phone': '861088326220'}, {'name': 'PING YIN', 'role': 'CONTACT', 'email': '13810080018@163.com', 'phone': '861088326220'}], 'overallOfficials': [{'name': 'XIN ZHI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Zhi Xin', 'investigatorAffiliation': "Peking University People's Hospital"}}}}